Normal Non-fluencyNCT01366781
Gut Hormones After Meal Ingestion in Males Versus Females
A study testing Meal ingestion in people with Normal Non-fluency, run by Lund University at 1 site in Sweden.
Trial summary
The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Non-fluency
- What is being tested?
- Meal ingestion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy status
Who cannot join
- Diabetes
- Liver disease
- kidney disease
- thyroid disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Clinical Sciences Lund, Lund University
Lund, 221 84
About this study
Official title: Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females
The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined.
Read the detailed description
In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon levels.
- Conditions
- Normal Non-fluency
- Being tested
- Meal ingestion
- Keywords
- Gut hormones, Insulin secretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal ingestionOther
Meal 511 kcal, meal 743 kcal or meal 1034 kcal
| Study group | Role | What they receive |
|---|---|---|
| Healthy males | Experimental | Meal ingestion in healthy males Receives: Other: Meal ingestion |
| Healthy females | Experimental | Meal ingestion in healthy females Receives: Other: Meal ingestion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Release of gut hormones
Measured: 300 min
Secondary outcomes (1)
Insulin secretion
Measured: 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Normal Non-fluencyStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Ahren, Lund University
- Investigators
- Bo Ahrén, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366781
- Sponsor's protocol ID
- 004
- Status last verified
- Sep 2014
- First submitted
- 31 May 2011
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Alsalim W, Omar B, Pacini G, Bizzotto R, Mari A, Ahren B. Incretin and islet hormone responses to meals of increasing size in healthy subjects. J Clin Endocrinol Metab. 2015 Feb;100(2):561-8. doi: 10.1210/jc.2014-2865. Epub 2014 Nov 6.
PubMed 25375983
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Varying Meal Size on Gut Hormone and Islet Hormone Secretion in Males Versus Females
- ClinicalTrials.gov ID
- NCT01366781
- Acronym / sponsor ID
- 004
- Conditions
- Normal Non-fluency
- Keywords
- Gut hormones, Insulin secretion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study hypothesis is that the release of gut hormones is increased proportionally to caloric load in each meal. Three different meals with different meal size will therefore be served and gut hormones determined.
Detailed description
In healthy males and females, meals with 511, 743 and 1034 kcal will be given orally. Samples will be taken during the following 300 min and gut hormones (glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1) will be determined along with insulin and glucagon levels.
Study design
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy males | Experimental | Other: Meal ingestionMeal ingestion in healthy males |
| Healthy females | Experimental | Other: Meal ingestionMeal ingestion in healthy females |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy status
Key exclusion criteria (4 listed)
- Diabetes
- Liver disease
- kidney disease
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal ingestionMeal 511 kcal, meal 743 kcal or meal 1034 kcal | Other | Healthy females, Healthy males |
Primary outcome
Release of gut hormones
Time frame: 300 min
1 secondary outcome
Insulin secretion
Time frame: 300 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Derived from this study: PubMed 25375983Alsalim W, Omar B, Pacini G, Bizzotto R, Mari A, Ahren B. Incretin and islet hormone responses to meals of increasing size in healthy subjects. J Clin Endocrinol Metab. 2015 Feb;100(2):561-8. doi: 10.1210/jc.2014-2865. Epub 2014 Nov 6.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Ahrén, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal ingestion in people with Normal Non-fluency, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Release of gut hormones (time frame: 300 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.